MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-3652ttsp fibertak rc suture anchor failed to deploy during a routine rotator cuff repair procedure for a supraspinatus tear on (b)(6) 2025.Upon inspection, the anchor¿s sheath exhibited resistance to bunching and deployment.There was no reported patient harm.Additional information was received on 07/10/2025: the case was completed as planned with another ar-3652ttsp fibertak rc suture anchor.There was no case delay or added anesthesia.No adverse effects were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation was confirmed by the customer's attached picture, which showed the anchor of the ar-3652ttsp frayed.

• Brand Name: SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22556917
• Report Number: 1220246-2025-02990
• Device Sequence Number: 9647118
• Product Code: MBI
• UDI-Device Identifier: 00888867362949
• UDI-Public: (01)00888867362949(11)240510(17)290430(10)15246499
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
• Device Catalogue Number: AR-3652TTSP
• Device Lot Number: 15246499
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown